Senior Biomaterials Engineer
2 weeks ago
Company Overview
Collagen Solutions is a leading manufacturer of tissue-based biomaterials for use in regenerative medicine and medical devices. We are a fast-paced growth company seeking a Principal Engineer to lead our structural heart device development team.
Job Summary
We are seeking a highly skilled Principal Engineer to lead the development of our structural heart devices. The ideal candidate will have a strong background in biomaterials and medical device design, with experience in developing and testing cardiovascular implants.
Key Responsibilities
- Lead the development of new structural heart devices, including transcatheter and surgical heart valves.
- Collaborate with cross-functional teams to research, develop, and secure regulatory approval for new regenerative medicine products.
- Design and test cardiovascular implants, including tissue selection, leaflet design, fabric integration, and ISO 5840 testing.
- Ensure compliance with industry standards and regulations, including FDA, MDD/MDR, ISO, ASTM, and ISO 13485.
- Mentor and train junior engineers to develop their skills and knowledge.
Requirements
- Minimum bachelor's degree in Material Science, Bioengineering, Chemistry, or related technical discipline.
- 10+ years of medical device and design control experience.
- Extensive knowledge of the industry and market conditions, specifically collagen, tissue, and other related biomaterials and contract development/manufacturing.
- Experience in tissue engineering and biomaterials is a plus.
- Ability to travel as needed (
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